Aseptic catheter assembly with holder introducer



May 20, 1969 I o. E. HARRELL 3,444,860

ASEPTIC CATHETER ASSEMBLY WITH HOLDER INTRODUCER Filed June 6, 1966 FIG.2

. INVENTOR.

050ml; I. flarrel! ATTORNEY United States Patent 3,444,860 ASEPTICCATHETER ASSEMBLY WITH HOLDER INTRODUCER Osmah E. Harrell, 2217 LaurelRoad, Jacksonville, Fla. 32207 Filed June 6, 1966, Ser. No. 555,551 Int.Cl. A61m 25/00 US. Cl. 128-349 8 Claims ABSTRACT OF THE DISCLOSURE Anaseptic catheter assembly including a lubricated catheter tube with acollection bag connected to one of the tube end portions and anelongated hollow, openended semi-rigid holder-introducer surrounding thetube at its opposite end portion with the tube being slideabletherethrough. The assembly further includes a flexible elongated tubularmembrane surrounding the tube with one of the membrane end portionsbeing attached to and outwardly around the holder-introducer between theends of the holder-introducer and the other membrane end portion beingattached to and externally around the tube adjacent the tube and bagconnection. A removable cap is provided closing the exposed end of theholder-introducer to maintain aseptic integrity of the assembly.

This invention relates to catheters and more particularly to an improvedcatheter assembly wherein the catheter is maintained in a sterilecondition until use.

Under the existing catheterization procedures, the doctor or nurse usingthe catheter must handle the catheter in directing and introducing thecatheter into the urethra and therethrough into the bladder. Thishandling of the catheter requires the operator to use sterile gloves orinstruments; and, even employing these cautionary procedures, there isstill a danger of the catheter becoming contaminated.

It is therefore an object of the subject invention to provide a catheterwhich can be maintained in a sterile condition before use and to collecturine using this catheter under sterile conditions.

Another object of this invention is to provide an improved disposablecatheter assembly.

A further object of the instant invention is to provide a means tocollect urine from patients under more sterile circumstances.

Still another object of the subject invention is to provide a steriledisposable catheter assembly wherein the catheter itself need not betouched or handled directly by human hands.

The novel features which are believed to be characteristic of thisinvention are set forth with particularity in the appended claims. Theinvention itself, however, both as to its organization and method ofoperation, together with further objects and advantages thereof, maybest be understood by reference to the following description taken inconnection with the accompanying drawing, in which:

FIG. 1 is a vertical elevation partially in section of a preferredembodiment of the disposable catheter assembly of this invention;

FIG. 2 is a plan view of the clamp used to seal off the neck of theflexible collection container of the invention;

FIG. 3 is a cross-sectional view taken along the line 3--3 of FIG. 1;and

FIG. 4 is a view similar to FIG. 3 of another embodiment of the catheterassembly of this invention.

Referring now to the drawings in detail the disposable catheter assemblyof this invention, generally designated by reference numeral is depictedin FIG. 1. The system "ice comprises a catheter tube 12 having a closedelliptical forward end 14 and terminating at an open rearward end 16.The catheter has a centrally disposed passageway or channel 18 runningits entire length and terminating at opening 20 in tube 12 adjacent itsforward end 14. The external surface of catheter tube 12 should besmooth, continuous and non-porous. It may be constructed of rubber or asuitable plastic such as polyethylene. The tube should be flexible buthave sutficient strength and longitudinal rigidity to permit insertionof the tube unaided by other devices into and through a tortuouspassageway within the body without collapsing.

The assembly further comprises a guide, holder or introducer 22 whichsurrounds and encloses catheter tube 12. This holder 22 is fabricatedfrom a hard rubber or plastic and is of a rigid or semi-rigidconstruction. The catheter tube 12 which is normally lubricated isslidable within passageway 24 of holder '22. Passageway 24 extends thefull length of holder or guide 22 terminating in an opening in therearward end 26 and an opening in the forward end 27 of guide or holder22. The purpose of holder 22 is to guide and direct the catheter intothe urethral opening of the patient. The holder 22 provides a placewhere the operator of the catheter may guide and direct travel of thecatheter from a point closely adj acent the urethral opening whileinsuring that the catheter tube itself is not touched. Forward end 27 ofholder 22 is provided with a pressure cap 28. This cap 28 is thesnap-off, snap-on type and is not in place when the catheter apparatusis in use, but is used when the device is not in use to insure sterilityof the catheter tube 12.

A flexible encasement or membrane 30 surrounds and seals catheter tube12 in a sterile condition rearward of holder 22. This flexibleencasement 30 is sealed at 32 to the rearward end 26 of holder 22 and at34 adjacent the rearward end 16 of catheter tube 12. The material ofthis membrane or encasement member 30 is of a very thin flexibleplastic, rubber or the like such that the catheter tube 12 may begripped through this encasement member 30 and gradually worked throughholder or guide 22 and inward of the urethra. The rearward end offlexible plastic encasement 30 is sealed to the catheter tube 12 at 34.The catheter tube 12 has its rearward end 16 connected to the neck 38 ofa sample collector or container 40. The neck 38 is provided with ridgesor corrugations 39 along the interior of its upper end to aid ingripping and securing the tube 12 within the neck 38. The bottom end offlexible plastic encasement 30 could be readily sealed to neck 38instead of the catheter tube 12 if so desired.

The sterile disposable catheter assembly of this invention is providedwith a clamp 44 constructed of metal or other suitable hard materiallike hard rubber or plastic. The purpose of this clamp 44 is to providea means of sealing the neck 38 of container 40 such that when asuflicient sample of urine has been collected in container 40 the neck38 may be sealed by the use of this slidable pinch clamp 44. This allowsthe catheter tube 12, holder 22 and flexible plastic encasement 30 to beremoved from the neck 38 of container 40, such that the container 40holding a sterile sample of urine may be transported to another area fortesting and examination. The clamp 44 is of a slidable and pinch typehaving a cutout portion 46 extending longitudinally through the centralportion of the clamp. One end 48 of this cutout portion is of a diameterand size sufficient to accommodate neck 38 in its completely open andexpanded size, while the other end 50 of this cutout portion is of asize which will pinch and completely close and seal neck 38 of container40. Normally clamp 44 will be in a position around neck 38 such that theneck passes through the larger end 48 of the cutout 46 such as to permitpassage of fluid through the neck 38 into container 40. When it isdesired to close olf and seal neck 38 once the container has the desiredamount of urine therein clamp 44 is moved in a sliding sidewarddirection relative to neck 38 such that neck 38 becomes positioned inthe smaller end 50 of cutout 46 of the clamp thus closing and sealingthe neck 38 of container 40.

The length of catheter tube 12 may vary over a wide range depending uponthe nearness desired of container 40 to holder 22 and flexible plasticencasement 30. Flexible plastic encasement 30 may also vary in dimensionbut should be at least eight inches in length when the catheter assemblyof this invention is to be used with female patients and no less thanfourteen inches in length when the catheter is to be employed with malepatients. Although the guide holder 22 may vary in dimension it shouldbe sufficiently long such that it can be conveniently gripped in onehand.

Holder or guide 22 of the catheter assembly of this invention is oftenof a multiple piece construction as is more clearly seen in FIG. 3. Asshown in FIG. 3 the guide 22 comprises two pieces, a larger member orsection 52 and a smaller wedge shaped member or element 54. The twomembers 52 and 54 fit together to form a generally solid and rigid tosemi-rigid structure encircling catheter tube 12, with the members 52and 54 engaging one another along cuts or lines 56 and 58 extending fromthe inner circumference to the outer circumference of the holder andbeing held in place by a thin cylindrical membrane 60. The membrane 60is shrunk around the cylindrical sleeve-like guide 22 during themanufacture thereof to securely hold the members 52 and 54 in place.While the members 52 and 54 shown in FIG. 3 are somewhat unequal insize, they could also readily be constructed to be of equal size or evensomewhat more unequal in size and still be satisfactory in use. Thisparticular construction of holder 22 of the catheter assembly isemployed so that once the catheter tube 12 is in place within theurethra and bladder of the patient, the holder 22 may be removed fromthe tube 12, this being accomplished by cutting thin membrane 60 andremoving members or sections 52 and 54 from the tube. Thus it is seenthat holder 22, flexible plastic encasement 30 and container 40 arecompletely removable from the catheter tube 12 once their functions havebeen fulfilled, thereby leaving only the tube 12 (now in a strippedcondition) in assocation with and portions thereof in engagement withthe patient. In this manner and condition portions of the catheter tube12 may be retained within the urethra and bladder of the patient andused to further drain the bladder and/ or treat the same, such as byadministering medications and drugs through the tube and into thebladder.

Another embodiment of the holder of the catheter assembly of thisinvention is depicted in cross-section in FIG. 4 at reference numeral22' surrounding and enclosing catheter tube 12. This construction of theguide or holder 22' is one-piece in nature having a small slot oropening 62 extending from the inner circumference to the outercircumference of the holder throughout its entire length. A strip ofadhesive type tape 64 extends across the outer opening of the slot 62throughout the length thereof to give the guide 22' a completelycircumferential construction and appearance. Opening or slot 62 may beformed in the holder 22' during the manufacture thereof or may be latercut into a previously formed continuous cylindrical body to result inthe guide 22' as depicted in FIG. 4. Once the catheter tube 12 has beeninserted into the urethra and bladder, and it is desired to remove theguide or holder 22 therefrom, tape 64 covering the outer opening of theslot 62 is removed and the sides of the slot 62 are spread apart andoutward to generally expand the holder 22 such that the catheter tube 12may be slipped through the now enlarged opening 62 and the holder 22freed from the catheter tube 12.

The catheter of this invention is prelubricated and sterile and remainsin this sterile condition until used. Because of the economicalmaterials used the catheter assembly of this invention is disposable.Even though the catheter is disposable it may also be easily and readilydisconnected from container 40 at neck 38 and resterilized, lubricatedand reused. Due to the novel arrangement of this catheter assembly, andin particular holder 22, the assembly may be employed without the use ofrubber gloves and without the need of handling the catheter itself.Therefore, not only is the catheter inserted without being directlyhandled with the liability of contamination from the fingers, but itsexposure to the atmosphere with the possibility of contamination, isgreatly reduced.

To use the catheter assembly, the cap 28 is removed from the end 27 ofholder 22 and the forward end 27 of holder 22 is aligned with and placedadjacent the entrance to the urethra. The operator of the assembly thengrasps the flexible plastic encasement 30 and gradually enters thecatheter into the urethra by gently pushing forward on the body of thecatheter 12 held through the flexible plastic encasement 30. This actionis maintained until the end 14 of catheter 12 reaches the bladder thusconstituting a duct for fluid discharge through opening 20 and downthrough passageway 18 of the catheter into container 40 after passingthrough neck 38. Once a suflicient sample of urine has been collected incontainer 40 the upper portion of the assembly including the holder 22,flexible plastic encasement 30, and catheter 12 may be removed fromcontainer 40 and neck 38 at the neck connection. The catheter 12 issufficiently flexible to direct the flow of the remainder of urine inthe bladder into another suitable receptacle. Once the container 40 hasbeen disconnected from catheter tube 12, slidable pinch clamp 44 may beoperated to close the neck 38 of the container and seal the sample ofurine therein. The container 40 with the urine sample therein may thenbe transported to a suitable area for testing, examination and study ofthe contents. After the bladder has been drained through the cathetertube 12, the tube with the holder 22 and flexible encasement 30 stillattached thereto can be removed from the bladder and urethra of thepatient; or the catheter tube may be stripped by removing the holder 22and flexible encasement 30 therefrom as hereinabove described, and beallowed to remain within the bladder and urethra of the patient forfurther drainage, testing, or treating of the bladder.

While only certain preferred embodiments of this invention have beenshown and described by way of illustration, \many modifications willoccur to those skilled in the art and it is, therefore, desired that itbe understood that it is intended in the appended claims to cover allsuch modifications as fall within the true spirit and scope of thisinvention.

What is claimed as new and what it is desired to secure by LettersPatent of the United States is:

1. In an aseptic, lubricated catheter assembly the combinationcomprising a flexible catheter tube having a forward end'portion, arearward end portion and a hollow passageway extending between said endportions and opening outwardly of said tube adjacent said end portions,a collection bag having a neck portion, said catheter tube rearward endportion being releasably connected to said neck portion of saidcollection bag, a generally cylindrical, semi-rigid holder remote fromsaid bag, said holder having a passageway extending therethrough withsaid catheter tube slidably disposed therein, a flexible, severableelongated membrane surrounding said catheter tube and attached to one ofits end portions to the rearward end portion of said holder and at itsother end portion to said catheter tube remote from said holder andadjacent the connection between said catheter tube and collection bag,said holder being externally hand grippable to orient the assemblyadjacent the urethral opening of a patient for guiding said cathetertube into the urethra, said catheter tube being workable through saidflexible membrane to move said tube through said holder and introducethe same through the urethra and into the bladder of a patient, and acap removably secured to the forward end portion of said holder tomaintain said catheter tube in an enclosed and aseptic state.

2. In an aseptic catheter assembly as defined in claim 1, a selectiveilyadjustable clamp mounted on and surrounding said neck portion of saidcollection bag operable selectively to open and to pinch closed saidneck portion of said bag.

3. In an aseptic catheter assembly as defined in claim 1, said holderhaving an openable, normally closed slit therein to permit lateralremoval of the holder from said catheter tube upon opening of said slit,and means temporarily closing said slit to preserve the asepticintegrity of the assembly.

4. In an aseptic catheter assembly as defined in claim 1 wherein saidholder comprises a plurality of elements, and releasable meansmaintaining said elements of said holder closely adjacent one another toform said holder, whereby upon release of said means said elements maybe separated to permit removal of said elements from said catheter tubewithout withdrawal of said catheter tube from a patient and withoutremoval of said collection bag from said catheter tube.

5. In an aseptic catheter assembly as defined in claim 1, said holderincluding a slot extending throughout the elongated dimension of saidholder communicating between said passageway and opening outwardly ofsaid holder, said slot being of a width less than said outer diameter ofsaid catheter tube, said holder being expandable to increase the widthof said slot to pass said catheter tube laterally through said slot, andreleasable means closing said slot, whereby upon release of said meanssaid holder is readily removable laterally of said catheter tube withoutwithdrawal of said catheter tube from a patient and without removal ofsaid collection bag from said catheter tube.

6. In a catheter assembly comprising an aseptic, lubricated cathetertube having opposite end portions, a collection bag releasably connectedto said catheter tube at one of its said end portions, a rigidholder-introducer surrounding said catheter tube at its opposite saidend portion, a flexible, severable elongated membrane surrounding saidcatheter tube and attached at one of its end portions to saidholder-introducer and at its other end portion to said catheter tubeadjacent the connection between said catheter tube and collection bag,said holderintroducer including a plurality of separable elements, saidelements upon separation thereof being radially removable from saidcatheter tube without withdrawal of said catheter tube from a patientand without removal of said collection bag from said catheter tube, andreleasable means maintaining said elements of said holderintroducerclosely adjacent to form said holder introducer.

7. In a catheter assembly comprising an aseptic, lubricated cathetertube having opposite end portions, a flexible collection bag releasablyconnected to said catheter tube at one of its said end portions, anelongated semi-rigid holder-introducer surrounding said catheter tube atits opposite said end portion, a flexible, severable, elongated membranesurrounding said catheter tube and attached at one of its end portionsto said holder introducer and at its other end portion to said cathetertube adjacent the connection between said catheter tube and collectionbag, said holder-introducer including an elongated slot extendinglongitudinally thereof with a. lateral dimension less than the diameterof said catheter tube, said holder-introducer being readily expandableto increase the lateral dimension of said slot to permit passage of saidcatheter tube therethrough and laterally of said holder-introducer, saidholder-introducer being easily removable laterally of said catheter tubewithout withdrawal of said catheter tube from a patient and withoutremoval of said collection bag from said catheter tube.

8. A catheter assembly comprising an aseptic catheter tube havingopposite end portions, a collection bag releasably connected to saidcatheter tube at one of its said end portions, an elongated hollow,open-ended, semirigid holder-introducer surrounding said catheter tubeat its opposite said end portion remote from said bag and said cathetertube being slideable therethrough, a flexible elongated tubular membranehaving opposite end portions and surrounding said catheter tube, saidmembrane being attached at one of its said end portions outwardly aroundsaid holder-introducer between the ends of said holderintroducer and atits said other end portion externally around said catheter tube remotefrom said holderintroducer adjacent the connection between said cathetertube and collection bag, a removable cap closing the exposed end of theholder-introducer to maintain aseptic integrity of the assembly, saidcatheter tube being manipulatable to slide through saidholder-introducer by grasping the outside of said membrane.

References Cited UNITED STATES PATENTS 1,120,549 12/1914 Schellberg128-349 2,856,932 10/1958 Griffitts 128294 2,937,643 5/1960 Elliot128--214.4 3,136,316 6/1964 Beall 128350 3,154,080 10/1964 Rowan et al128349 3,169,527 2/1965 Sheridan 128349 3,330,278 7/1967 Santomieri1282l4.4

FOREIGN PATENTS 322,426 12/ 1929 Great Britain.

OTHER REFERENCES Lancet, Sept. 14, 1963, p. 557.

DALTON L. TRULUCK, Primary Examiner.

US. Cl. X.R.

UNITED STATES PATENT OFFICE CERTIFICATE OF CORRECTION Patent No. 4,Dated May 1969 Osmah E. Harrell It is certified that error appears inthe above-identified patent and that: said Letters Patent. are herebycorrected as shown below:

Column 3, line 18, after "guide" insert or Column 5, line 56, the word"radially" should read readily SIGNED ANu SEALED FEB a 7 (SEAL) IAttest:

EdwardM.Flewher,Ir.

WILLIAM E. 50mm; JR. Attesung Officer Oomissioner of Patents

